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Description:

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Principal Regulatory Compliance Specialist located in Danvers, MA.

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

The Principal Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Senior Regulatory Compliance Manager will be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated CSS sites and with the Regulatory Compliance teams of other regions and business groups. The Senior Regulatory Compliance Manager is expected to collaborate with other groups within the J&J Regulatory Compliance (JJRC) organization to support execution of independent audits and special assessments and deploy compliance initiatives.

Key Responsibilities:

• Lead and manage site audit readiness activities to ensure inspection readiness at all time. Schedule and handle mock inspections as part of External Inspection Readiness activities. Provide timely information to support the inspection process, including those that maybe taking place at other sites / locations.
• Establish and implement an effective internal audit schedule for site against established internal audit procedures. Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive timely completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure. Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements.
• Drive compliance in internal audit metrics. Create reports and communicate performance against metrics to cross-functional groups. Highlight/communicate adverse trends in metrics and take risk-based action to remediate. Assure that required compliance-related events (e.g., field actions, inspections) are entered into the appropriate system.
• Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Provide internal audit inputs/updates to Quality System Management Reviews to allow meaningful review of their tasks.
• Participate in JJRC audits as requested. Support the creation and effective deployment of internal J&J Quality System and/or Compliance standards

Qualifications:

Education

• BA/BS with 8 years of relevant work experience in medical Device, such as ISO 13485, etc.

Required:

• Experience leading audit readiness activities
• Experience with CAPA investigations
• Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry
• Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units
• Balanced technical understanding of products and processes combined with outstanding business and compliance acumen
• High tolerance for ambiguity in a complex environment
• Ability to discern critical issues amidst broad operating nit complexity and to engage and achieve executive management support for proactive and reactive measures. Ability to make the complex clear and easily understood by others

Preferred:

• Current certification in quality system auditor or lead auditor

Other:

• Ability to travel up to 10% domestically
• Must be willing to relocate to Danvers, MA

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $100,000 to $150,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.